Combination Chemotherapy Plus Bevacizumab With or Without Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer
Summary
This randomized phase III trial studies how well combination chemotherapy plus bevacizumab with or without oxaliplatin works in treating older patients with colorectal cancer that has spread to other places in the body. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. Bevacizumab may also stop the growth of cancer by blocking blood flow to the tumor. It is not yet known whether combination chemotherapy plus bevacizumab is more effective with or without oxaliplatin in treating colorectal cancer.
Timeline
- Start
- 2011-01
- Primary completion
- 2014-11
- Completion
- 2014-11-01
Outcome
Missed primary endpoint
Stopped (Enrollment): “Slow accrual”
registry analysis (superiority or other test); Arm A [Fluoropyrimidine + Bevacizumab (BEV)] vs Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV]; p = 0.93 NCT01279681 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | — | Oral |
| Subject | Leucovorin | Small molecule | — | Intravenous |
| Subject | Oxaliplatin | Small molecule | — | Intravenous |
| Subject | fluorouracil | Small molecule | — | Intravenous |
| Background | Bevacizumab | Monoclonal antibody | — | Intravenous |